Clinical Research Quality Assurance Specialist III

About the role

Tekton Research is seeking a remote Quality Assurance Specialist III to lead and advance quality assurance efforts across a clinical research site network. This senior-level role involves overseeing complex audits, driving process improvement initiatives, managing compliance risks, and serving as a subject matter expert (SME) in clinical research compliance to ensure the integrity of clinical trials and alignment with regulatory requirements.

Responsibilities

• Conduct in-depth internal audits of clinical research activities, including investigator site files, informed consent processes, source documentation, and data integrity.
• Evaluate compliance with GCP, ICH guidelines, FDA/EMA regulations, and sponsor requirements.
• Oversee inspection readiness activities, including mock inspections, and act as a QA representative during regulatory inspections.
• Identify, evaluate, and manage quality risks across the site network, prioritizing areas for mitigation.
• Develop and oversee quality improvement plans to address systemic risks.
• Lead root cause analyses and the development of complex Corrective and Preventive Action (CAPA) plans.
• Monitor CAPA implementation, ensure effectiveness, and report outcomes to senior leadership.
• Design and implement site-wide quality improvement initiatives, ensuring alignment with industry best practices.
• Develop and update Standard Operating Procedures (SOPs), work instructions, and quality manuals.
• Provide advanced training to QA team members and clinical staff on quality assurance, regulatory compliance, and auditing.
• Mentor junior and mid-level QA professionals, supporting their development and growth within the organization.
• Act as a subject matter expert in regulatory requirements, providing guidance to clinical operations, regulatory affairs, and other stakeholders.
• Collaborate with internal and external stakeholders to address quality-related issues and ensure trial integrity.
• Prepare comprehensive audit reports and executive summaries for leadership review.
• Analyze quality metrics to identify trends, opportunities for improvement, and areas of excellence.
• Perform other duties as assigned.

Requirements

• In-depth knowledge of GCP, FDA/EMA regulations, ICH guidelines, and clinical trial processes.
• Excellent written and oral communication, attention to detail, organizational, and planning skills.
• Ability to perform and maintain quality work while prioritizing and managing multiple deadlines.
• Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint).
• Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), or similar platforms.
• Proven ability to conduct audits and prepare detailed audit reports.
• Demonstrated experience leading audits and managing regulatory inspections.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field (Master’s degree preferred).
• 5–7 years of experience in quality assurance, clinical research, or regulatory compliance, with significant experience in a QA leadership role.
• Experience working in a multi-site clinical research organization or network.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Approximately 50% travel, with the possibility of increased travel during peak periods or as project needs demand.
• Must be able to lift up to 15 pounds at times.

Reports to: Quality Assurance Manager